Bordier affinity products S.A.

Address:Chatanerie 2,Crissier Vaud,CH

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Antigen, Agglutinating, Echinococcus Spp. (GPF) (3) Elisa, Trichinella Spiralis (MDT) (2) Antigen, Fluorescent Antibody Test, Schistosoma Mansoni (GNH) (1) Device, General Purpose, Microbiology, Diagnostic (LIB) (1) Reagents, Cysticercosis (MDJ) (1) Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp. (KHW) (1) Antigen, Cf, Aspergillus Spp. (JWT) (1)

Premarket Exempt

Yes

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Aspergillus fumigatus IgG ELISA - 07640158216101 Catalog Number : 6100

Device Description : The Aspergillus fumigatus ELISA test is a qualitative enzyme immunoassay for the The Aspergillus fumigatus ELISA test is a qualitative enzyme immunoassay for the detection of Aspergillus fumigatus antibodies in human serum samples.

Device Class : 1

Duns Number: 487811143

Premarket Exempt : Yes

Product Code : JWT

Prescription Use : No

Device Count : 1

Toxocara canis IgG ELISA - 07640158219201 Catalog Number : 9200

Device Description : The Toxocara canis ELISA test is a qualitative enzyme immunoassay for the detect The Toxocara canis ELISA test is a qualitative enzyme immunoassay for the detection of Toxocara canis antibodies in human serum samples.

Device Class : 1

Duns Number: 487811143

Premarket Exempt : Yes

Product Code : MDJ

Prescription Use : No

Device Count : 1

Ascaris IgG ELISA - 07640158219256 Catalog Number : 9250

Device Description : The Ascaris ELISA test is a qualitative enzyme immunoassay for the detection of The Ascaris ELISA test is a qualitative enzyme immunoassay for the detection of Ascaris in human serum samples.

Device Class : 1

Duns Number: 487811143

Premarket Exempt : Yes

Product Code : MDT

Prescription Use : No

Device Count : 1

Echinococcus multilocularis (Em2-Em18) IgG ELISA - 07640158219300 Catalog Number : 9300

Device Description : The Echinococcus multilocularis (Em2-Em18) ELISA test is a qualitative enzyme im The Echinococcus multilocularis (Em2-Em18) ELISA test is a qualitative enzyme immunoassay for the detection of Echinococcus multilocularis antibodies in human serum samples.

Device Class : 1

Duns Number: 487811143

Premarket Exempt : Yes

Product Code : GPF

Prescription Use : No

Device Count : 1

Echinococcus multilocularis (Em18) IgG ELISA - 07640158219317 Catalog Number : 9310

Device Description : The Echinococcus multilocularis (Em18) ELISA test is a qualitative enzyme immuno The Echinococcus multilocularis (Em18) ELISA test is a qualitative enzyme immunoassay for the detection of Echinococcus multilocularis antibodies in human serum samples.This test is intended for post-operative and/or post-therapeutic follow-up of infected patients.

Device Class : 1

Duns Number: 487811143

Premarket Exempt : Yes

Product Code : GPF

Prescription Use : No

Device Count : 1

Echinococcus granulosus IgG ELISA - 07640158219355 Catalog Number : 9350

Device Description : The Echinococcus granulosus ELISA test is a qualitative enzyme immunoassay for t The Echinococcus granulosus ELISA test is a qualitative enzyme immunoassay for the detection of Echinococcus granulosus (and Echinococcus multilocularis) antibodies in human serum samples.

Device Class : 1

Duns Number: 487811143

Premarket Exempt : Yes

Product Code : GPF

Prescription Use : No

Device Count : 1

Acanthocheilonema viteae IgG ELISA - 07640158219409 Catalog Number : 9400

Device Description : The Acanthocheilonema viteae ELISA test is a qualitative enzyme immunoassay for The Acanthocheilonema viteae ELISA test is a qualitative enzyme immunoassay for the detection of Acanthocheilonema viteae antibodies in human serum samples.

Device Class : 1

Duns Number: 487811143

Premarket Exempt : Yes

Product Code : LIB

Prescription Use : No

Device Count : 1

Strongyloides ratti IgG ELISA - 07640158219454 Catalog Number : 9450

Device Description : The Strongyloides ELISA test is a qualitative enzyme immunoassay for the detecti The Strongyloides ELISA test is a qualitative enzyme immunoassay for the detection of Strongyloides antibodies in human serum samples.

Device Class : 1

Duns Number: 487811143

Premarket Exempt : Yes

Product Code : MDT

Prescription Use : No

Device Count : 1

Entamoeba histolytica IgG ELISA - 07640158219553 Catalog Number : 9550

Device Description : The Entamoeba histolytica ELISA test is a qualitative enzyme immunoassay for the The Entamoeba histolytica ELISA test is a qualitative enzyme immunoassay for the detection of Entamoeba histolytica antibodies in human serum samples.

Device Class : 2

Duns Number: 487811143

Premarket Exempt : Yes

Product Code : KHW

Prescription Use : No

Device Count : 1

Schistosoma mansoni IgG ELISA - 07640158219607 Catalog Number : 9600

Device Description : The Schistosoma mansoni ELISA test is a qualitative enzyme immunoassay for the d The Schistosoma mansoni ELISA test is a qualitative enzyme immunoassay for the detection of Schistosoma mansoni and Schistosoma haematobium antibodies in human serum samples.

Device Class : 1

Duns Number: 487811143

Premarket Exempt : Yes

Product Code : GNH

Prescription Use : No

Device Count : 1

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